Job Description Summary Join us, the future is ours to shape!Job Description Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape! Your Key Responsibilities: Your responsibilities include, but not limited to: UK National PV point of contact Act as the National Contact Person for PharmacovigilanceCollaborate and work with the UK-QPPVLeadership and Influence: Lead and oversee pharmacovigilance activities within the local Affiliate.Advocate for local Affiliate’s needs at local, regional, and global levels.Promote a comprehensive understanding of the PV system within the organization.Ensure adherence to local safety requirements.Represent the local Affiliate(s) in cross-functional and global-regional-local frameworks.Drive the integration of safety procedures within the organization.Establish strong partnership with the local Affiliate leadership and ensure exchange of key pharmacovigilance topicsExternally influence the local regulatory environment by participating in key local pharmacovigilance associationsLine management accountability and operational leadership of affiliate Patient Safety StaffInformation Flow and Collaboration: Facilitate efficient exchange of safety-related information within the Affiliate and within the PS organization (UK-QPPV, Patient Safety Regional Lead).Collaborate with the following but not limited to local business partners, Patient Safety regional leads, QPPV, and third-party vendors.Safety Expertise and Support: Stay informed about Sandoz product safety profiles.Support launches of Sandoz products in the territory by providing pharmacovigilance expertise during all phases of product development.Communicate with the local Health Authority as appropriateProvide safety expertise for marketed and investigational products.Support risk management plans and additional risk minimization measures (aRMMs) implementation.Oversight: Develop, implement and maintain oversight mechanisms for safety related activities conducted in the Affiliate and keep the compliance.Ensure compliance with local pharmacovigilance laws and quality standards.Quality Management System: Contribute to the local quality management system.Contribute to maintenance of the local UK PSMF (PV System Master File)Engage in training, records management, and regulatory intelligence.Ensure audit and inspection readiness.Host and lead local inspections and auditsWhat you’ll bring to the role: Essential Requirements: Professional qualification in Health Care Sciences (e.g., Medical Doctor, Pharmacist, Nurse)/ Master's Degree or EquivalentMinimum 10 years in drug safety or pharmacovigilance with 3 years of demonstrated leadership.Excellent communication skills in English. Knowledge of other languages is desirableExtensive understanding of local pharmacovigilance requirements, with the ability to address complex regulatory issues.Proficient in pharmacovigilance processes, including compliance, databases, procedures, quality assurance, and training.Proven ability to critically evaluate and integrate data from diverse areas/domains.Effective communication skills with various stakeholders.Experience in pharmacovigilance audits and inspections.Demonstrated ability for innovative and strategic thinking.Strong planning, negotiation, organizational, and interpersonal skills.Proficiency in computer and IT systems.You’ll receive: Competitive salary, Annual bonus, Pension scheme, Health insurance, 24 days annual leave, Flexible working arrangements, Employee recognition scheme, learning and development opportunities Why Sandoz? Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more! With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported! Join us! Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Join our Sandoz Network:If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here:Sandoz Talentpool () #Sandoz Skills Desired Clinical Trial, Databases, Employee Training, Pharmacovigilance, Reporting, Safety Science, Team Management, Waterfall Model #J-18808-Ljbffr
Job Title
Senor Patient Safety Manager